Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial

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City, University of London Institutional Repository

Citation

: Oblasser, C., McCourt, C., Hanzal, E. and Christie, J. (2015). Vibrating vaginal

balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial. Journal Of Advanced Nursing, 72(4), pp. 900-914. doi: 10.1111/jan.12868

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Table 1: Inclusion and exclusion criteria

Inclusion criteria:

 Women from 6 weeks to 6 months after vaginal childbirth (at beginning of intervention)

 Term birth, i.e. 37+0 or more weeks of gestation

 6 weeks postpartum check by obstetrician-gynaecologist performed and woman

discharged from postpartum care with diagnostic findings appropriate to this period after

childbirth

 Lochia have ceased

 Over the age of 18 with capacity to consent

 Sufficient knowledge of written and spoken German to be able to participate in the study

 Baby alive/not seriously ill

Exclusion criteria:

 Currently enrolled in pelvic floor muscle training with physiotherapist, midwife or fitness

trainer

 Status post perineal tear 3rd or 4th degree at most recent birth

 Status post continence surgery

 Current pelvic floor or gynaecological surgery

 Current infection of genitourinary tract

 Recurrent (>5 infectious episodes during last 12 months) or chronic (>3 weeks duration

of single episode in last 12 months) vaginal infections

 Neuromuscular conditions influencing pelvic floor muscle function (e.g. multiple

sclerosis)

 Major medical condition influencing infectious risk (diabetes, immune suppressive

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 Currently on medication that could interfere with treatment or evaluation

 Currently enrolled in any other research study

 Pregnancy (also commencing during participation) or pregnancy planned within the study

period

 Retention of ball is impossible

 Inability to perform the proposed procedures

Table 2: Feasibility criteria: the full trial will deemed to be feasible if all of the following criteria are met.

Recruitment:

 ≥ 10% of eligible persons give consent to participate in the trial (can only be

calculated for recruitment where professionals will note the number of eligible

women).

Pre intervention data collection:

 At least 50 of the 56 or ≥ 90% (95%CI=80-100) of participants attend the first pelvic

floor muscle measurement within 3 weeks of consenting to take part in the trial.

Completion and concordance:

 At least 50 of the 56 or ≥ 90% (95%CI=80-100) of participants start with the

intervention within 4 days of the initial pelvic floor muscle measurement by

perineometry.

 At least 45 of the 56 or ≥ 80% (95%CI=70-90) of enrolled participants keep to the

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Post intervention data collection:

 At least 45 of the 56 or ≥ 80% (95% CI=70-90) of enrolled participants have the final

[image:4.595.65.530.252.730.2]

data collection within 2 weeks of ending the intervention.

Table 3: Summary of data collection

Variable(s) Timepoint Method of collection

Feasibility variables (see

criteria in table 2)

Throughout study and at the

end of trial data collection

Calculation

Staff, time, and budget

necessary

Throughout study Noting down in a list,

calculation

Baseline variables Before the intervention Structured interview

Participant reported pelvic

floor outcome measures

Before and after the

intervention

Structured questionnaire to

be completed by participant

Technically assessed pelvic

floor muscle performance

intervention

Physiological measurement

by perineometry

Women´s perspectives and

experiences

intervention OR after the

intervention

Structured interview OR

structured anonymous

questionnaire

Concordance Throughout study Training diary

Adverse events/harm Throughout study Phone interviews, question

in final interview/survey,

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[image:5.842.170.792.99.516.2]

Table 4: Schedule of enrolment, interventions, and assessments

Study period

Enrolment Allocation Post-allocation Close-out

-t3 -t2

7-10 days after –t3 -t1 not before six weeks after birth 0 = -t1 t1 = -t1/0 t2

within 2 weeks of t1

t3-t7 t8

within 2 weeks after ending the intervention

t9

within 2 weeks after ending the intervention

1. Enrolment

Recruitment Via

different routes Recruitment

Initial eligibility screen

Phone call (15 min.) (for those concerned)

Eligibility screen a

Informed consent a

2. Allocation a

3 .Interventions Starts after

perineometry x (12 weeks) 4. Assessments Baseline variables collection a Participant reported outcome variables collection

a c

Perineometry b b

Interviews

OR questionnaire

a c

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Adverse events monitoring

5 phone calls (à 5-10 min.)

c

a = personal meeting of CO with the potential participant, on the venue most suitable to the participant (her home, hospital room or public place where sufficient privacy can be obtained). Estimated duration: 2 hours.

b = by masked assessor (EH): Participants have to travel to Vienna General Hospital. Estimated duration of contact: 15 minutes. Travel time according to participant.

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[image:7.842.65.793.92.501.2]

Table 5: Items from the World Health Organization Trial Registration Data Set

Primary Registry and

Trial Identifying Number

www.clinicaltrials.gov

NCT02355327

Date of Registration in Primary Registry January 2015

Secondary Identifying Numbers Lead Ethics Committee: Ethics Committee of the Medical University of Vienna, 1704/2014

(October 2014)

Ethics Committee: Senate Research Ethics Committee of City University London, SREC 14-15

02 D 02 12 2014 (January 2015)

Source(s) of Monetary or Material Support City University London

Northampton Square

London EC1V 0HB

United Kingdom

Medizinische Universität Wien (Medical University of Vienna)

Spitalgasse 23

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Austria

Primary Sponsor City University London

Northampton Square

London EC1V 0HB

United Kingdom

Secondary Sponsor Medizinische Universität Wien (Medical University of Vienna)

Spitalgasse 23

1090 Wien

Austria

Contact for Public Queries Claudia Oblasser

School of Health Sciences

City University London

1 Myddelton Street

London EC1R 1UW

Tel: +(0) 20 7040 8337

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Contact for Scientific Queries As above

Public Title Feasibility study on the effectiveness of vibrating vaginal balls to improve pelvic floor muscle

performance in women after childbirth [translated from German]

Scientific Title Feasibility trial on the effectiveness of vibrating vaginal balls to improve pelvic floor muscle

performance in women after childbirth

Country of Recruitment Austria

Health Condition or Problem Studied Pelvic floor health after childbirth

Interventions _ _{Experimental device: Laselle Kegel Exerciser}

Participants use a vibrating pelvic floor muscle training ball for 12 weeks. The ball is inserted

into the vagina and left for 15 minutes daily in the first week, and if well tolerated 30 minutes

daily from the second week onwards. To achieve the vibrating effect, the balls are worn while

moving – performing everyday tasks or going for a walk.

 Active behavioural control: Pelvic floor muscle exercises

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muscle exercises. Participants will be asked to continue/start the pelvic floor muscle exercises

they routinely were recommended by customary written instructions from their health

professionals after birth.

 Intervention duration for this study is 12 weeks.

Key Inclusion and Exclusion Criteria See table 1

Study Type and Design Study type: interventional

Allocation: randomised

Intervention Model: parallel assignment

Masking: single blind (outcome assessor)

Purpose: feasibility trial

Date of First Enrollment February 2015

Target Sample Size 56

Recruitment Status Recruiting

Primary Outcomes _ _{Feasibility as measured by recruitment rate (Timepoint: within 4 weeks of ending}

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 Feasibility as measured by pre intervention pelvic floor muscle measurement attendance rate

(Timepoint: within 4 weeks of ending data collection)

 Feasibility as measured by start of intervention rate (Timepoint: within 4 weeks of ending

data collection)

 Feasibility as measured by concordance rate (Timepoint: within 4 weeks of ending data

collection)

 Feasibility as measured by retention rate (Timepoint: within 4 weeks of ending data

collection)

 Feasibility as measured by post intervention data collection attendance rate

(Timepoint: within 4 weeks of ending data collection)

 Feasibility as measured by staff necessary (Timepoint: within 4 weeks of ending data

collection)

 Feasibility as measured by time necessary (Timepoint: within 4 weeks of ending data

collection)

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collection)

Key Secondary Outcomes _ _{Participant reported pelvic floor muscle outcomes as measured by structured questionnaire}

(Timepoint: within 3 weeks before the intervention)

 Participant reported pelvic floor muscle outcomes as measured by structured questionnaire

(Timepoint: within 2 weeks after the intervention)

 Pelvic floor muscle performance as measured by perineometry (Timepoint: within 4 days

before the intervention) – by masked assessor

 Pelvic floor muscle performance as measured by perineometry (Timepoint: within 2 weeks

after the intervention) – by masked assessor

 Women´s perspectives and experiences as measured by structured interviews

(Timepoint: within 3 weeks before the intervention) – 28 of 56 women

 Women´s perspectives and experiences as measured by structured interviews

(Timepoint: within 2 weeks after the intervention) – same 28 of 56 women as for previous

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 Women´s perspectives and experiences as measured by structured anonymous questionnaire

(Timepoint: within 3 weeks after the intervention) – 28 of 56 women (those not included

in the two previous outcome measures)

 Concordance to interventions as measured by training diary (Timepoint: at time of

intervention (12 weeks))

 Type, severity and number of adverse events as measured by active and passive surveillance

(interview, self-report) (Timepoint: at time of intervention (12 weeks))

 Type, severity and number of adverse events as measured by active and passive surveillance

(interview/questionnaire, self-report) (Timepoint: up to 1 year after end of intervention) –